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Completed

NCT Number: NCT04679597

Total Neoadjuvant Therapy Versus Standard Therapy of Locally Advanced Rectal Cancer With High Risk Factors for Failure

In a retrospective study, the investigators will compare patients with locally advanced rectal cancer with high risk factors for failure who were treated with standard therapy or with total neoadjuvant therapy.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • histologically proven locally advanced rectal cancer and
  • the presence of one of the factors: T4, N2, positive mesorectal fascia, presence of extramural vascular invasion or presence of lateral lymph node.

Exclusion criteria

  • distant metastases,
  • concomitant malignancy,
  • inflammatory bowel disease, or
  • malabsorption syndrome.

Treatment and study plan

Capecitabine

Drug

comparison of two treatments

Other names: oxaliplatin

Primary outcomes

  1. pathological complete response

    Time frame: during surgery

    pathological complete response is defined as the absence of tumor cells in the surgical resection

Secondary outcomes

  1. Neoadjuvant rectal cancer score

    Time frame: during treatment, assessed up to 10 days

    Neoadjuvant rectal cancer score: The NAR score was calculated using the equation [5 pN - 3(cT - pT) + 12]^2 / 9.61 and further classified as low (< 8), intermediate (8-16), or high (< 16).

Other outcomes

  1. number of participants who completed treatment

    Time frame: during treatment, assessed up to 10 days

    Compliance - number of participants who completed treatment protocol

  2. number of participants with acute side effects

    Time frame: during treatment, assessed up to 10 days

    Acute toxcity - number of participants with side effects during different treatment modality

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Dec 22, 2020
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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